First-in-human trial focusing on the immunologic effects of the survivin-derived multiepitope vaccine EMD640744.

2515 Background: Survivin is a promising antigen for cancer immunotherapy based on two major criteria: tumor cells depend on its actions, and it has demonstrated immunogenicity in patients with different cancers. Here we report immunomonitoring results of a first-in-man Phase I study (EMR 200032-001) with EMD640744, a cocktail of survivin-derived partially modified HLA class I-restricted peptides in Montanide ISA 51 VG. This multicenter, open-label, parallel group, randomized study compared the immunologic efficacy, safety, tolerability and clinical activity of 3 dosages of sc EMD640744 (30, 100 or 300 µg) in patients with different types of metastatic or locally advanced solid tumors positive for at least one relevant HLA antigen (A1, A2, A3, A24, B7). Methods: Routine immunomonitoring to analyze peptide-specific T cell responses at baseline and at weeks 4, 8, 12, 16, and 17 was performed by IFN-γ ELISpot and peptide/HLA-multimer staining (primary endpoint). Additional analyses were performed by intracel...